Senior Study Lead - GMP Labs
Core
Lead complex routine analytical testing programmes (release, stability, quality control) in a GMP laboratory setting to support drug development and manufacturing.
Role type
Senior Study Lead (GMP Analytical Testing)
Builds
High-quality GMP analytical testing services for small molecule pharmaceuticals
Domain
Life Sciences / Pharmaceutical Manufacturing / Analytical Chemistry
Required skills
GMP compliance, analytical instrumentation (HPLC, UPLC, dissolution, Karl Fischer, FTIR), study planning, technical documentation, root cause analysis, CAPA management, project management, mentoring
Preferred skills
ICH guidelines knowledge, Phase 3 clinical studies experience, Power BI, LIMS
Technologies
HPLC, UPLC, dissolution testers, Karl Fischer titrators, FTIR, LIMS, Microsoft Office, Power BI
Responsibilities
Lead and coordinate multiple complex routine analytical testing projects; Draft, review and approve technical documentation including protocols and reports; Oversee investigations, deviations and risk-based assessments; Act as key technical contact for clients; Drive audit and inspection readiness; Evaluate data trends and technical KPIs; Coach and mentor Study Leads and colleagues
Seniority
Senior, hands-on IC with mentorship responsibilities
